Green Compass Reduce Roll-on Pain Relief

Description

REDUCE is a roll-on pain relief formulation that incorporates menthol and 300 mg of full spectrum hemp flower extract. This product is manufactured by Green Compass and is available in a dosage form of 2 fluid ounces (60 mL). The combination of menthol and hemp extract is designed to provide targeted relief for discomfort.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate dosage and administration guidelines tailored to the child's specific needs.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse effects. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to increased risk of burns or skin damage.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, it is imperative to avoid using this product in conjunction with a heating pad, as this may increase the risk of burns or other complications. Care should be taken to prevent contact with the eyes, as exposure may result in significant irritation. Furthermore, when applying the product, it is advised not to bandage the area tightly, as this could impede circulation and lead to further complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if the condition appears to resolve only to recur within a few days.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds or damaged skin and should not be used in conjunction with a heating pad. While using this product, patients are advised to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and recurs within a few days, patients should discontinue use and consult a healthcare professional. Additionally, this product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Green Compass Reduce Roll-on Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

There is no information available regarding the use of Green Compass Reduce Roll-On Pain Relief during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and should weigh the potential benefits against any unknown risks to fetal outcomes. Due to the lack of data, no specific dosage modifications or special precautions can be recommended for use during pregnancy.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be considered as part of standard clinical practice.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, as this may lead to adverse effects. Additionally, it is important to caution patients against using the product in conjunction with a heating pad, as this may increase the risk of burns or other complications.

Healthcare providers should encourage patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be advised to seek medical advice if their condition appears to improve but then recurs within a few days.

While using the product, patients must be reminded to avoid contact with the eyes to prevent irritation or injury. Furthermore, it is essential to instruct patients not to bandage the area tightly when using the product, as this may impede circulation and lead to further complications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Green Compass Reduce Roll-on Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)